FDA Lays Out New Path to Speed Development of Multiple Myeloma Drugs

FDA lays out new path to speed development of multiple myeloma drugs

In certain cases, regulators will now be open to clearing therapies based on their ability to eliminate tumor cells, a development that could aid development of cell therapies and other new medicines.

FDA Issues Draft Guidance on MRD and CR End Points in Multiple Myeloma | Targeted Oncology - Immunotherapy, Biomarkers, and Cancer Pathways

The FDA released draft guidance on minimal residual disease and complete response as trial end points to accelerate multiple myeloma drug approvals.

FDA Draft Guidance Proposes CR, MRD to Accelerate MM Drug Approval

The FDA believes that data on MRD and complete response can expedite new drug delivery compared with long-term survival indicators.

J&J praises new FDA guidance to speed development of multiple myeloma drugs

Johnson & Johnson, which has several drugs approved for multiple myeloma, praised the FDA's just-released draft guidance on how the agency will allow the use of minimal residual disease as a primary endpoint for accelerated ...

FDA Issues Guidance on MRD, CR Outcomes for Multiple Myeloma Approvals

According to the FDA, randomized trials are preferred when assessing MRD to support accelerated approvals in multiple myeloma.